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A Study to Describe Treatment Patterns of Advanced Breast Cancer in Poland in the Real-world Data Setting

NCT ID: NCT05478590

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-22

Study Completion Date

2022-09-30

Brief Summary

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The study is descriptive and aims to characterize the treatment patterns of advanced breast cancer in Poland in the real-world data setting. The main goals are to assess the current treatment patterns of hormone receptor-positive (HR+) Human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer and their changes in clinical practice and relate them to patients' demographics, disease characteristics, type of other therapies used in patients as well as disease progression and visceral crisis occurrence.

Detailed Description

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Conditions

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Breast Neoplasms

Keywords

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Hormone receptor-positive human epidermal growth factor receptor 2 negative (HR+ HER2-) advanced breast cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adult patients with histologically diagnosed advanced breast cancer (with locoregional recurrence not eligible for radical local treatment or with distant metastases)
* Patient has a documented hormone (estrogen and/or progesterone) receptor expression and lack of HER2 receptor overexpression or lack of HER2 gene amplification (HR+/HER2- breast cancer subtype)
* Patient had no prior treatment for advanced breast cancer
* Patient has no symptomatic metastases to the central nervous system
* There is no other malignancies in patient requiring active treatment
* Patient is without co-occurring other malignancies treated with palliative assumption

Exclusion Criteria

* Parallel patient's participation in any other clinical trial at the time when the decision over the advanced breast cancer treatment was made or up to 30 days before it.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Ambulatorium Chemioterapii Centrum Onkologii

Bydgoszcz, , Poland

Site Status

Wojewodzki Szpital Zespolony w Elblągu - oddzial onkologii

Elblag, , Poland

Site Status

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, , Poland

Site Status

Oddział onkologii Szpital Specjalistyczny im. H. Klimontowicza

Gorlice, , Poland

Site Status

Oddział Onkologii Klinicznej

Kalisz, , Poland

Site Status

Narodowy Instytut Onkologii

Krakow, , Poland

Site Status

Oddział Onkologii Klinicznej z Pododdziałem Dziennym

Krakow, , Poland

Site Status

Klinika Onkologii, Instytut Centrum Zdrowia Matki Polki

Lodz, , Poland

Site Status

Opolskie Centrum Onkologii

Opole, , Poland

Site Status

Oddział/Poradnia Onkologiczna Wojewodzki Szpital w Przemyślu

Przemyśl, , Poland

Site Status

Podkarpackie Centrum Onkologii

Rzeszów, , Poland

Site Status

SPZOZ Oddział onkologii klinicznej

Swidnica, , Poland

Site Status

Zachodniopomorskie Centrum Onkologii

Szczecin, , Poland

Site Status

Izerskie Centrum Pulmonologii i Chemioterapii "Izer-Med" Sp. z o.o

Szklarska Poręba, , Poland

Site Status

Specjalistyczny Szpital Onkologiczny NU-MED

Tomaszów Mazowiecki, , Poland

Site Status

Centralny Szpital Kliniczny MSWiA w Warszawie

Warsaw, , Poland

Site Status

Pfizer Polska

Warsaw, , Poland

Site Status

Wojewodzki Szpital Specjalistyczny we Wroclawiu

Wroclaw, , Poland

Site Status

Dolnośląskie Centrum Onkologii

Wroclaw, , Poland

Site Status

Countries

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Poland

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A5481177

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Other Identifiers

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A5481177

Identifier Type: -

Identifier Source: org_study_id